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Adnexal Mass After Methotrexate Treatment for Ectopic Pregnancies

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Ectopic Pregnancies

Treatments

Other: BHCG monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT03138694
614-16-TLV

Details and patient eligibility

About

Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

Full description

Ectopic pregnancies are a common morbidity in the gynaecological field. Previous work done by our team has shown the benefits of conservative treatment with only BHCG (Beta-Human Chorionic Gonadotropin) monitoring, proving that a vast number of patients will have a self resolution without the need for any further medical intervention. In addition, our working hypothesis is that this process in contrast to Methotrexate is a more physiologic one with less inflammatory and necrosis reaction.

OBJECTIVE To measure and compare the size of the ectopic mass and monitor BHCG levels of women treated with Methotrexate and those that had a self resolution process of their ectopic pregnancy.

Investigators aim to prove that the mass will have an enlargement trend after Methotrexate in contrast to being stable or decrease in size with conservative treatment.

PATIENTS & METHODS Patients that will be offered to join the study are those that will be with either treated by a Methotrexate injection or those that had signs of self resolution with our "Watchful waiting" protocol.

Enrollment

500 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All patients admitted and treated for a diagnosis of Ectopic pregnancy in The Department of Gynecology, Lis Maternity Hospital.

Exclusion criteria

none

Trial design

500 participants in 2 patient groups

Methotrexate injection
Description:
Patients with Ectopic pregnancy treated with Methotrexate injection.
Treatment:
Other: BHCG monitoring
Self resolution
Description:
Patients with Ectopic pregnancy that had signs of self resolution with our "Watchful waiting" protocol.
Treatment:
Other: BHCG monitoring

Trial contacts and locations

0

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Central trial contact

Ishai Levin, professor

Data sourced from clinicaltrials.gov

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